An established form of acoustic pulse therapy, extracorporeal shockwave therapy, is used in physical therapy, orthopedics, urology and cardiology. The shockwaves are abrupt, high amplitude pulses of mechanical energy, similar to sound waves. Shockwaves were originally used in medicine for breaking up kidney stones using a procedure known as lithotripsy. This is a high intensity application of acoustic pulse therapy that is used to disrupt and destroy kidney stones.
LEAP therapy uses a much lower energy form of acoustic pulses than traditional shockwaves and can be applied for treatment of tissues, rather than to destroy them. Various forms of LEAP treatment devices are currently available, but there remains a continuing need for LEAP apparatus tailored to specific applications for which the therapy is being applied. In particular, LEAP apparatus are needed which can deliver a relatively uniform amount of acoustic pulse energy to the entire target tissue.
U.S. Patent Application Publication No. 2012/0239055 A1 to Spector et al. discloses a method for treating the female pelvic floor and perineal organs with extracorporeal shockwaves. Although treatment of urinary incontinence is mentioned in a long list of potential uses, there are no specific teachings for successfully completing such treatment. Further, in general, the shockwave generating device can be inserted through the vaginal canal to treat Urethral Syndrome. This exposes the vaginal canal to the extracorporeal shockwaves, which could result in damage thereto, or other unintended consequences, including, but not limited to pain. Still further, the shockwave device produces a focal zone and thereby applies shockwave energy at substantially different levels to different portions of the target tissue being treated. Also, being a focused device, the device of Spector et al would require applying shockwaves from multiple different positions along the length of the vaginal canal, as the wave width is only sufficient to apply to a small portion of the urethra from each application location within the vaginal canal. Because of inherent differences in the sizes and geometries of vaginal canals among various patients, there would also be a need to adjust the size of the probe of Spector et al. in order to accommodate fits to different sizes of vaginal canals. Patients with vaginal canals smaller than the minimum feasible size of the probe could not be treated at all.
U.S. Application Publication No. 2014/0330174 A1 to Warlick et al. discloses a method of treatment of vaginal tissue inflamed or damaged by complications from use of surgical mesh, which method includes emission of acoustic shock waves which can be convergent, divergent, planar or near planar. The devices of Warlick et al. use a parabolic reflector with an electrohydraulic device to provide divergent, planar or nearly planar wave patterns. However, the present inventors' observations have been that electrohydraulic devices with parabolic reflections do not produce planar waves. There is no specification by Warlick et al. as to the size or shape of an energy field produced by any of the embodiments shown, nor any teaching as to what a desired or appropriate energy field would look like. Further, if the target site is the vaginal tissue or organ subjected to a surgical procedure exposing at least some if not all of the tissue or organ within the body cavity the target site may be such that the patient or the generating source must be reoriented relative to the site and a second, third or more treatment dosage can be administered. Thus, because all of a significant volume of the target site cannot be captured by application of shockwaves from a single location, this complicates the procedure and also adds to the expense of the procedures required. It is also disclosed that a key advantage of the methodology of U.S. Application Publication No. 2014/0330174 A1 is that it is complementary to conventional medical procedures. There is no disclosure of treating female urinary incontinence by this method alone. The methods described are primarily directed to early prevention therapies to stimulate tissue or organ modeling to be maintained within acceptable ranges prior to an exposure to a degenerative condition occurring. This is disclosed to be valuable in the prevention of age related complications from later implantation of screen mesh for example. Shock waves can be emitted through the perineum tissue at the skin's surface and directed to the vaginal tissue or pelvic organs into the pelvic cavity. Alternatively, the shock waves can be administered via a vaginal probe that can emit spherical waves or planar waves. This vaginal probe simply can be directed into contact with the vaginal tissue to be treated. With either method the emitted waves are directed to the vaginal tissue or the pelvic organ. Treatment of the urethra along its length from either a vaginal or a perineal location would require multiple positions of the shockwave emitter, and a vaginal approach would suffer the same size drawbacks as noted above.
U.S. Pat. No. 9,161,768 to Cioanta et al. discloses extracorporeal shockwave devices with reversed applications. For example, a long reflector having an elongated shape and multiple discharge points is disclosed. The penetration depth to be achieved by the shockwave will dictate the depth of the reflector shape, which can be shallow for superficial applications or very deep for applications where the focus is deep inside the human body. In each case the shockwaves are focused and would not deliver a relatively uniform amount of energy to a target tissue.
Applicator information for DERMAGOLD 100® and ORTHOGOLD100® probes by MTS Shockwave Technology and Lithotripsy shows waveforms for probes that generate shockwaves by the electrohydraulic principle. Even those waveforms that are referred to as “unfocused” (e.g., OP155 waveforms shown on page 2 of the brochure) are focused to a degree, as illustrated by the red coloration in the center portion of the waveform that is surrounded by the yellow coloration in the remainder of the waveform. Because of the lack of uniformity of the waveforms, and the inability of the waveforms to achieve a sufficient width for a sufficient length at a sufficient power level, these devices are not sufficient to therapeutically treat the female urethra from a single treatment location, due to the diameter (including the urethral sphincter muscles) and length of the female urethra, which average about 16 mm and 4 cm, respectively. Although there are waveforms of the DERMAGOLD 100® apparatus that include 14 mm, 16 mm and greater focal diameters, these waveforms are not uniform, as they are more concentrated along the central axis of the waveform and the full width of the waveform does not extend over a length of 4 cm. These waveforms cannot effectively envelop the urethra and urethral sphincter muscles sufficiently for use in treating the female urethra. Furthermore, the energy flux density (EFD) levels required to achieve focal diameters of 15 mm-16 mm, i.e., 0.12-0.13 mJ/mm2, are too high to be tolerated by a patient being treated in the area of the female urethra. As the EFD levels decrease, the focal diameters of the waveforms of the DERMAGOLD 100® apparatus also decrease, and thereby have even less ability to envelop the urethra and urethral sphincter muscles. There remains a need for improvement in energy level uniformity through an energy field over the space that encompasses the target tissue that therapy is being applied to.
There remains a need for improved apparatus that applies an appropriate energy level of LEAP to a target tissue and applies it more uniformly over the target tissue.
There remains a need for improved apparatus that applies desired amounts of energy via LEAP to a target tissue, while minimizing the amounts of energy applied to tissues adjacent to the target tissue.
There remains a need for improved apparatus that can achieve a therapeutic result from application of LEAPs from only one location, without the need to reposition the apparatus or patient and reapply LEAPs.
There remains a need for improved apparatus that can achieve a therapeutic result from application of LEAPs from only one location, along the length of the female urethra, to effectively treat female urinary incontinence, without the need to reposition the apparatus or patient and reapply LEAPs from a second or additional locations, and wherein the LEAPs applied are at a power level to produce a maximum energy flux density that is applied to the target tissue that is tolerable to the patient, so as not to produce intolerable pain or tissue damage.
There remains a need for apparatus that are more user friendly and easier for the user to operate, including performance of targeting and application of therapy.